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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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239 supplements returned for P030005

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Device Name Company Date Approved Supplement Reason Other Information
crt-p resynchronization devices: invive, intua, visionist and valitude

supplement #: S182
Guidant Corp. Jul 08, 2019 change design/components/specifications/material  
crt-p resynchronization devices invive, intua, visionist, valitude

supplement #: S183
Guidant Corp. Jun 10, 2019 change design/components/specifications/material  
invive, intua, visionist and valitude crt-p resynchronization devices

supplement #: S184
Guidant Corp. Jul 08, 2019 change design/components/specifications/material  
accolade crt – pacemakers (crt-ps)

supplement #: S185
Guidant Corp. Jun 21, 2019 process change - manufacturer/sterilizer/packager/supplier  
valitude and visionist non-mri crt-ps and valitude x4 and visionist x4 mri crt-ps

supplement #: S186
Guidant Corp. Sep 18, 2019 change design/components/specifications/material  
visionist and valitude (crt-p)

supplement #: S187
Guidant Corp. Jul 18, 2019 process change - manufacturer/sterilizer/packager/supplier  
crt-p resynchronization devices: invive, intua, visionist, and valitude

supplement #: S188
Guidant Corp. Oct 18, 2019 change design/components/specifications/material  
valitude, valitude x4, visionist, and visionist x4 cardiac resynchronization therapy - pacemaker (crt-p)

supplement #: S189
Guidant Corp. Sep 24, 2019 process change - manufacturer/sterilizer/packager/supplier  
cardiac resynchronization therapy - pacemaker (crt-p)

supplement #: S190
Guidant Corp. Oct 29, 2019 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p is1/is4 el, visionist crt-p is1 el and visionist crt-p lv1 el

supplement #: S191
Guidant Corp. Nov 27, 2019 process change - manufacturer/sterilizer/packager/supplier  
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